Latest Drugwonks' Blog
If you’re following the multifaceted and global debate over biosimilars, Steve Usdin’s article, Biosimilar battlefronts, is a must read. Authored by BioCentury's Steve Usdin, it’s opening paragraphs set the tone,
Biosimilars developers, manufacturers of originator biologics, payers and consumer groups are battling in state capitals, at FDA headquarters, and at the World Health Organization in Geneva over the rules that will shape perceptions and prescribing practices for copycat biologics in the U.S. and around the world.
Separately, none of the conflicts will have a decisive effect on either biosimilars developers or manufacturers of the products they hope to replace. But collectively, state laws on interchangeable biosimilar substitution, national and international naming practices, and FDA's labeling policies could have powerful effects on the market penetration of biosimilars.
The article covers many issues, both foreign and domestic – and one of the most important and most contentious is the issue of the nonproprietary names assigned to biosimilar and interchangeable biologics.
Usdin writes,
Proponents of distinctive non-proprietary names, including some of the biggest biotech companies, say patient safety and possibly the viability of whole classes of biologic drugs would be threatened by a failure to adopt their recommendations.
However, European regulators say distinct non-proprietary names are unnecessary, and some biosimilars companies argue such a naming scheme would put a dark cloud over biosimilar products that would substantially reduce sales.
A WHO group will meet on Oct. 22 to debate biosimilars naming principles.
The basic disagreement: one camp is arguing for biosimilars to keep the same international non-proprietary name (INN) as the reference product; a second camp argues for distinct INNs.
Supporters of distinct INNs say the ability of regulators to track and trace biologic drugs is essential for patient safety and the commercial viability of biologics — original and biosimilar. Opponents of distinct INNs say they are intended to confuse and scare physicians, patients and payers by drawing unnecessary distinctions between original biologics and biosimilars.
According to Geoffrey Eich, executive director of R&D policy at Amgen, “It seems counterintuitive, like sticking your head in the sand, to not want to include a distinguishing feature that allows us to aggregate info when appropriate and disaggregate when appropriate.”
Amgen supports the use of the reference product’s root INN, with the addition of a unique suffix or prefix for each biosimilar. “We believe having some kind of a distinguishable feature is absolutely essential to patient welfare, for pharmacovigilance,” Amgen’s Eich told BioCentury.
A WHO working group will meet Oct. 22-24 to discuss the creation of voluntary international standards for non-proprietary names for biosimilars.
WHO isn’t likely to adopt a final naming policy at the October meeting. Whatever policy it eventually adopts will not be binding, but it is likely to be adopted by developing countries, and, if it includes a distinctive naming system, could intensify pressure on European countries to adopt new naming policies.
Without casting any aspersions, “quality” and “pharmacovigilance” in developing countries takes on an entirely different meaning than similar concepts in more developed regulatory regimes.
At a meeting in Pretoria last week Tomas Salmonson, Chair of the EMA’s Committee for Medicinal Products for Human Use (CHMP), said that the working group is “split down the middle” on the issue of naming.
Stay tuned.
We do what we must, and call it by the best names. -- Ralph Waldo Emerson
BioCentury This Week is must see TV – especially if you work in the FDA’s government affairs office.
On this weekend’s program Representative Dr. Mike Burgess (R, TX) said that the OMB misinterpreted the law – and that user fees shouldn't have been sequestered.
Dr. Burgess’ comments can be found here.
Dr. Charles Inturrisi is Professor of Pharmacology at Weill Cornell Medical College. He also has appointments in the Neuroscience Program at WCMC and with the Pain and Palliative Care Service, of the Memorial Sloan-Kettering Cancer Center and with the Drug Abuse Center at The Rockefeller University.
Dr. Inturrisi's current research is measuring the long term outcomes of treatments for chronic cancer and noncancer pain received by patients at four hospital-based outpatient Pain Clinics. He continues to have an interest the role of glutamate receptors in injury-induced pain and opioid tolerance, dependence and addictive behaviors. His research is directed at the discovery of new treatments for pain and drug addiction.
Dr. Inturrisi has received the John J. Bonica award of the Eastern Pain Association, a Distinguished Alumnus award from the University of Connecticut and the Excellence in Mentoring Award, Weill Cornell Medical College Postdoctoral Association. In 2008, Dr. Inturrisi received the first Graduate Dean’s Award for Excellence in Teaching and Mentoring of Graduate Students, presented by the Weill Cornell Graduate School of Medical Sciences.
He served as the president of the American Pain Society from 2008 to 2010 and in 2013 received the Distinguished Service Award from APS.
He was a member of the Institute of Medicine Committee that prepared the 2011 Report entitled “Relieving Pain in America”.
You can listen to Dr. Inturrisi’s presentation here (at the 1:03 mark) and the panel discussion that followed here.
Judy Foreman is a nationally syndicated health columnist whose “Health Sense” columns have appeared regularly in the Boston Globe, Los Angeles Times, Dallas Morning News and other national and international outlets. For years, she also wrote the Globe’s popular short feature, “Health Answers.”
She graduated Phi Beta Kappa from Wellesley College, served in the Peace Corps in Brazil for three years, then got a Master’s degree from the Harvard Graduate School of Education. From 2001 to 2004, she was a Lecturer on Medicine at Harvard Medical School and, for most of this time, was a scholar at the Brandeis Women’s Research Center. She has also been the host of a weekly, call-in radio show on Healthtalk.com and has won more than 50 journalism awards.
Her book on chronic pain, “A Nation in Pain – Healing Our Biggest Health Problem,” is due out in January, 2014 from Oxford University Press.
Steve Usdin has been Washington Editor of BioCentury since 1993, and has spent the past 20 years in the nation's capital covering political and policy issues affecting the life sciences sector. He also is the host of BioCentury This Week, BioCentury's weekly public affairs television program, as well as BioCentury Senior Editor responsible for coverage of social issues involving biotechnology. Steve’s reporting about biotechnology and biomedical policy has been cited in The Economist, The Wall Street Journal, the Washington Post, New Scientist and other publications. In 2012, the FDA Alumni Association named Steve the Harvey W. Wiley Lecturer, making him the first journalist to receive the Wiley Award. His book, “Engineering Communism: How Two Americans Spied for Stalin and Founded the Soviet Silicon Valley,” was published in 2005 by Yale University Press.
You can listen to Judy Foreman’s presentation and the panel discussion moderated by Peter Pitts here.
India's Protectionist Prescription
At the recent Group of 20 Summit, Indian Prime Minister Manmohan Singh implored American policymakers to recommit to encouraging robust growth in India and other emerging markets. It was a surprising request from a leader who has spent the past year overseeing a barrage of damaging reforms that threaten the American economy — and India’s prosperity.
India has been systematically shutting out foreign goods in an effort to prop up domestic industries. Indian officials have recklessly ignored basic intellectual-property protections, unfairly bolstering their own businesses at the expense of improved public health. America’s leaders need to make clear that a fair and open relationship benefits both India and the United States. If India wants to remain a valued economic partner, this kind of crude protectionism won’t be tolerated.
In recent months, India’s policymakers have pulled out all the stops to give homegrown companies an unfair advantage. Since the beginning of last year, the government has raised customs duties on high-end cars from 75 percent to 100 percent. In April, leaders mandated that all cosmetic products be registered with the Indian government prior to marketing there — a bureaucratic hurdle designed to obstruct foreign firms. Yet another new regulation requires that procurements by the country’s military give priority to Indian defense firms.
All together, the country has enacted 33 potentially trade-restricting measures since October 2008, according to a recent report from the European Commission. Where India’s self-serving policies have been especially irresponsible, however, is in the area of intellectual property, particularly for cutting-edge pharmaceuticals.
The country’s blatant disregard for intellectual-property rights was made clear in April, when India’s Supreme Court denied patent protection for a new form of the cancer drug Gleevec. In doing so, the court gave India’s $22 billion domestic drug industry free rein to sell copycat versions of the treatment. Indian officials were quick to declare the decision a victory for their poorest citizens, applauding the court for helping to make sophisticated medicines more affordable.
This claim, however, entirely misrepresents the decision and its consequences. Officials strategically neglected to mention that 95 percent of Indians who rely on Gleevec already receive the drug free of charge, thanks to a program supported by the drug’s manufacturer, Novartis. The Gleevec case was never about improving pharmaceutical access; the real intent was always to benefit India’s drug manufacturers.
By unfairly boosting the country’s generic industry, the court announced to health care research firms around the world that India is no friend to cutting-edge treatments — and the repercussions of such a message could be severe.
A breakthrough drug such as Gleevec requires, on average, more than a decade of trial and error to create and costs firms more than $1 billion. If India isn’t willing to protect the basic intellectual-property protections companies need to earn back some of that investment, drug firms won’t be able to offer their products to Indian patients, much less give them away for free. Considering India is home to the largest population of people who lack access to essential drugs, Indian leaders can ill afford to shun foreign pharmaceutical companies and the advanced medicines they offer.
Additionally, there is the direct threat India’s policies pose to the American economy. U.S. exports to India totaled $33 billion in 2011, an increase of more than 12 percent from the year before. As Rep. John B. Larson, Connecticut Democrat, and Rep. Erik Paulsen, Minnesota Republican, noted in a recent letter to fellow lawmakers in Congress, no fewer than 75 U.S. industries depend on intellectual-property protections. All told, companies in these fields are responsible for roughly 40 million American jobs.
America’s technology, agriculture and information-technology industries — among other sectors — are already feeling the effects of India’s current policies. If India continues to erect trade barriers, more and more U.S. firms will be denied a valuable and growing market for their goods.
What’s more, if our leaders don’t reverse this protectionist shift, many other nations may follow suit. In fact, many already have: The European Commission found that between May 2012 and May 2013, 154 new trade-restricting measures were adopted around the world, while only 18 were lifted.
As Mr. Singh made clear at the G-20 summit, America continues to have considerable influence on India’s economic future. It’s time our leaders use this clout to pressure India’s government to abandon their destructive trade policies. Officials in Washington must demonstrate to India — and the world — that fair economic partnerships are mutually beneficial and that protectionist tactics won’t be tolerated.
Peter J. Pitts, a former associate commissioner at the Food and Drug Administration, is president of the Center for Medicine in the Public Interest.
Another biologics nomenclature Citizen Petition was filed before this (see www.biopharmacopeia.com). The GPhA petition concerns the issue of established/official nonproprietary names (useable for marketing and prescription filling), particularly, whether these should be unique or not (generic). The earlier petition was filed in June by the Biotechnology Information Institute (R. Rader). It requests FDA assign both unofficial unique and biosimilar/(bio)generic-like (or class) names (and/or other identifiers) upon biologics approvals, along with public disclosures of needed basic agent/product descriptive information, including regarding supplemental approvals (product drift). These names (and the nomenclature system) need to be coherent science/entity/product-based, i.e., totally new and with no connection or carry-over from INN/USAN, which as a legacy pre-recombinant nomenclature system is simply not workable with modern biologics.
Thank you.
Ronald A. Rader
President
Biotechnology Information Institute
CMPI president Peter Pitts’ opening remarks at the conference can be found here.
In the next audio clips, Steve Usdin of BioCentury moderates a panel discussion addressing the role of patients and manufacturers as it concerns access to pain medications.
The panelists are listed below:
Cindy Steinberg, National Director of Policy and Advocacy, US Pain Foundation
Bob Twillman, Director of Policy and Advocacy, American Academy of Pain Management
Stuart Kim, Associate General Counsel, Regulatory Affairs, Mallinckrodt Pharmaceuticals
You can listen to Cindy Steinberg’s presentation and the panel discussion moderated by Steve Usdin here.
In an interview with in-PharmaTechnologist.com, India’s Deputy Drug Controller, S. Eshwar Reddy, said some pretty honest – and frightening things about his nation’s perspective on global good manufacturing practices (GMP) – or purposeful lack thereof.
When asked if Indian manufacturers -- which produce more than 40 per cent of the API used in the US and Europe -- should be more sympathetic with Western guidelines and regulations, Reddy said the opposite should be true.
He said any additional requirements made are the sole responsibility of the authority which issues them.
“If the importing country has specific GMP requirements, that is their responsibility to audit the facilities. It is the responsibility of the importing country not the exporting country.”
Talk about passing the rupee.
“Being the Indian drug regulatory authority we don’t have any monitoring mechanism of other countries’ regulations. Each country has their own set of laws so Indian regulatory authorities don’t have any control.
So much for global regulatory fraternity.
BioCentury reports that the Generic Pharmaceutical Association has requested (via Citizen's Petition) that the FDA allow biosimilar and interchangeable biologics to use the same international non-proprietary name (INN) as reference biologics. GPhA said requiring different INNs for biosimilars and the original biologic would "inaccurately suggest that these products have meaningful clinical differences for patients."
The petition asserts that FDA lacks legal authority to require separate INNs for biosimilars. GPhA also noted that FDA has allowed originator biologics, including antihemophilic factors, to share an INN even if they differ in manufacturing method.
The agency is developing a guidance document on naming biosimilars and interchangeable biologics. According to Rachel Sherman, CDER’s Director of the Office of Medical, the naming policy will be designed to ensure that products can be tracked and traced, "Pharmacovigilance is our prime concern; we need to know who is getting what." noted Sherman.
Smart money (and savvy public health practice) predicts the petition will be denied.
Last night I attended an elegant dinner at the New York Public Library (sponsored by Johnson & Johnson and Scientific American) where the 2013 Dr. Paul Janssen Award for Biomedical Research was presented to Dr. David Julius.
Dr. Julius received the award for his role in identifying the molecular mechanisms of touch, pain, and thermosensation. A scientific slam-dunk.
The highlight of the evening wasn’t the chicken and rice pilaf – it was Dr. Julius’ speech where he highlighted the inherent tension (“not conflict”) between the translational research and “curiosity-based science.”
A bold topic in a room filled with J&J’s top brass.
And an important topic for a number of reasons, not the least of which is the steady decrease on NIH funding for academia (a trend likely to continue unless they strike oil in Bethesda) and the nascent uptick in the outsourcing of pharma R&D to ivy-covered halls.
Per Dr. J, academe and industry and Uncle Sam are going to have to find new ways not only to mutually co-exist – but also to fruitfully collaborate.
At the end of the day it’s all about encouraging innovation, both incremental and discontinuous.
(I asked Dr. Julius to send me his remarks, and when they arrive I will be sure to post them.)
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
